China-based Ascletis Pharma Inc. (HKG: 1672) announced that the first patient has been dosed in a clinical study for its PD-L1 antibody ASC22 (envafolimab) in combination with chidamide for the functional cure of human immunodeficiency virus (HIV) infection. The study was initiated by the Shanghai Public Health Clinical Center. This follows the completion of the first patient dosing in the Phase II trial of envafolimab as a monotherapy for HIV-1 immune restoration.
Drug Profile
Envafolimab is the world’s first subcutaneously administered single-domain antibody against PD-L1, with potential to restore virus-specific immune responses in chronic viral infections. Originated by Alphamab Oncology (HKG: 9966) and co-developed with 3D Medicines since January 2019, Ascletis gained rights to envafolimab for viral diseases in 2019. The drug received US approval for chronic hepatitis B functional cure trials in January 2022 and started HIV trials in China the next month.
Chidamide Background
Chipscreen’s chidamide, a first-in-class HDAC inhibitor, has been marketed in China since 2014 for peripheral T-cell lymphoma and approved in 2019 for advanced breast cancer. The drug was licensed to Meiji Seika Pharma in multiple Asian countries in 2020.-Fineline Info & Tech
